Rheumatoid Arthritis (RA)Phase 2NCT07864688
Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis
A Phase 2 study testing Dapagliflozin, Empagliflozin and Methotrexate in people with Rheumatoid Arthritis (RA), run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy and safety of dapagliflozin and empagliflozin as adjunctive therapies to methotrexate in patients with rheumatoid arthritis who have active disease despite stable methotrexate treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Dapagliflozin, Empagliflozin and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years.
- Diagnosed with rheumatoid arthritis according to the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria.
- Receiving stable methotrexate therapy for at least 12 weeks.
- Active rheumatoid arthritis (DAS28-CRP >3.2) despite methotrexate therapy.
- Willing to participate, able to provide informed consent, and able to comply with study requirements.
Who cannot join
- Pregnancy or lactation.
- Current use of any sodium-glucose cotransporter 2 (SGLT2) inhibitor.
- Severe renal or hepatic impairment.
- Active or recurrent urinary or genital infections.
- Type 1 diabetes mellitus or history of diabetic ketoacidosis (DKA).
- Known hypersensitivity to dapagliflozin, empagliflozin, or any of their components.
- Participation in another clinical trial within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Zahraa University Hospital
Cairo, Cairo Governorate
Enas A. El-Shorbagy, M.Sc. in Clinical Pharmacy, +0201123339227, enas-elshorbagy@eru.edu.eg
Enas A. El-Shorbagy, M.Sc. in Clinical Pharmacy
About this study
Official title: Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial
This study aims to evaluate the efficacy and safety of dapagliflozin and empagliflozin as adjunctive therapies to methotrexate in patients with rheumatoid arthritis who have active disease despite stable methotrexate treatment. The study will compare three groups: methotrexate plus dapagliflozin 10 mg once daily, methotrexate plus empagliflozin 10 mg once daily, and methotrexate alone. Participants will be followed for 3 months. The primary outcome is the change in Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months. Secondary outcomes include changes in serum matrix metalloproteinase-3 (MMP-3), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and assessment of safety and tolerability.
Read the detailed description
This is a prospective, randomized, controlled, parallel-group, open-label clinical trial that will be conducted at the Rheumatology Outpatient Clinic of Al-Zahraa University Hospital, Cairo. The study will include adult patients aged 18 to 65 years with rheumatoid arthritis diagnosed according to the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria, who have been receiving stable methotrexate treatment for at least 12 weeks and have active rheumatoid arthritis despite methotrexate therapy. A total of 90 participants will be enrolled and randomly allocated in a 1:1:1 ratio into three groups, with 30 participants in each group. Group I will receive dapagliflozin 10 mg once daily in addition to standard methotrexate therapy for 3 months. Group II will receive empagliflozin 10 mg once daily in addition to standard methotrexate therapy for 3 months. Group III will receive standard methotrexate therapy alone for 3 months. Clinical and laboratory assessments will be performed at baseline and after 3 months. Disease activity will be assessed using the Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP). Laboratory assessments will include serum matrix metalloproteinase-3 (MMP-3), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), complete blood count, alanine aminotransferase, aspartate aminotransferase, serum creatinine, and estimated glomerular filtration rate. Safety and tolerability will also be assessed throughout the study. The primary outcome is the change in DAS28-CRP from baseline to 3 months. Secondary outcomes include the change in serum MMP-3 concentration from baseline to 3 months, assessment of adverse drug reactions, and treatment discontinuation due to adverse drug reactions.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Dapagliflozin, Empagliflozin, Methotrexate
- Keywords
- Dapagliflozin, Empagliflozin, Methotrexate, SGLT2 Inhibitors, DAS28-CRP, MMP-3
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy.
EmpagliflozinDrug
Empagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy
MethotrexateDrug
Standard methotrexate therapy for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin + Methotrexate | Experimental | Dapagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months. Receives: Drug: Dapagliflozin; Drug: Methotrexate |
| Empagliflozin + Methotrexate | Experimental | Empagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months. Receives: Drug: Empagliflozin; Drug: Methotrexate |
| Methotrexate Alone | Active comparator | Standard methotrexate therapy alone for 3 months. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months
Change in disease activity assessed using the Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months. The DAS28-CRP score ranges from 0 to 9.4, with higher scores indicating greater rheumatoid arthritis disease activity (worse outcome).
Measured: Baseline to 3 months
Secondary outcomes (3)
Change in serum matrix metalloproteinase-3 (MMP-3) concentration from baseline to 3 months
Change in serum matrix metalloproteinase-3 (MMP-3) concentration from baseline to 3 months. Serum matrix metalloproteinase-3 (MMP-3) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline to 3 months
Number and percentage of participants experiencing at least one adverse drug reaction during the 3-month treatment period
Number and percentage of participants experiencing at least one adverse drug reaction during the 3-month treatment period. Adverse drug reactions will be assessed based on clinical assessment and participant reporting.
Measured: Baseline to 3 months
Number and percentage of participants with treatment discontinuation due to adverse drug reactions
Number and percentage of participants who permanently discontinue study treatment because of an adverse drug reaction during the 3-month treatment period.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Ahmed Mohamed Elshorbagy, Egyptian Russian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864688
- Sponsor's protocol ID
- AZU-RA-SGLT2-2026-001
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dapagliflozin and Empagliflozin as Adjunctive Therapy to Methotrexate in Patients With Rheumatoid Arthritis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07864688
- Acronym / sponsor ID
- AZU-RA-SGLT2-2026-001
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Dapagliflozin, Empagliflozin, Methotrexate, SGLT2 Inhibitors, DAS28-CRP, MMP-3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of dapagliflozin and empagliflozin as adjunctive therapies to methotrexate in patients with rheumatoid arthritis who have active disease despite stable methotrexate treatment. The study will compare three groups: methotrexate plus dapagliflozin 10 mg once daily, methotrexate plus empagliflozin 10 mg once daily, and methotrexate alone. Participants will be followed for 3 months. The primary outcome is the change in Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months. Secondary outcomes include changes in serum matrix metalloproteinase-3 (MMP-3), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and assessment of safety and tolerability.
Detailed description
This is a prospective, randomized, controlled, parallel-group, open-label clinical trial that will be conducted at the Rheumatology Outpatient Clinic of Al-Zahraa University Hospital, Cairo. The study will include adult patients aged 18 to 65 years with rheumatoid arthritis diagnosed according to the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria, who have been receiving stable methotrexate treatment for at least 12 weeks and have active rheumatoid arthritis despite methotrexate therapy. A total of 90 participants will be enrolled and randomly allocated in a 1:1:1 ratio into three groups, with 30 participants in each group. Group I will receive dapagliflozin 10 mg once daily in addition to standard methotrexate therapy for 3 months. Group II will receive empagliflozin 10 mg once daily in addition to standard methotrexate therapy for 3 months. Group III will receive standard methotrexate therapy alone for 3 months. Clinical and laboratory assessments will be performed at baseline and after 3 months. Disease activity will be assessed using the Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP). Laboratory assessments will include serum matrix metalloproteinase-3 (MMP-3), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), complete blood count, alanine aminotransferase, aspartate aminotransferase, serum creatinine, and estimated glomerular filtration rate. Safety and tolerability will also be assessed throughout the study. The primary outcome is the change in DAS28-CRP from baseline to 3 months. Secondary outcomes include the change in serum MMP-3 concentration from baseline to 3 months, assessment of adverse drug reactions, and treatment discontinuation due to adverse drug reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin + Methotrexate | Experimental | Drug: Dapagliflozin, Drug: MethotrexateDapagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months. |
| Empagliflozin + Methotrexate | Experimental | Drug: Empagliflozin, Drug: MethotrexateEmpagliflozin 10 mg orally once daily in addition to standard methotrexate therapy for 3 months. |
| Methotrexate Alone | Active comparator | Drug: MethotrexateStandard methotrexate therapy alone for 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-65 years.
- Diagnosed with rheumatoid arthritis according to the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria.
- Receiving stable methotrexate therapy for at least 12 weeks.
- Active rheumatoid arthritis (DAS28-CRP >3.2) despite methotrexate therapy.
- Willing to participate, able to provide informed consent, and able to comply with study requirements.
Key exclusion criteria (7 listed)
- Pregnancy or lactation.
- Current use of any sodium-glucose cotransporter 2 (SGLT2) inhibitor.
- Severe renal or hepatic impairment.
- Active or recurrent urinary or genital infections.
- Type 1 diabetes mellitus or history of diabetic ketoacidosis (DKA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy. | Drug | Dapagliflozin + Methotrexate |
| EmpagliflozinEmpagliflozin 10 mg orally once daily for 3 months, in addition to standard methotrexate therapy | Drug | Empagliflozin + Methotrexate |
| MethotrexateStandard methotrexate therapy for 3 months. | Drug | Dapagliflozin + Methotrexate, Empagliflozin + Methotrexate, Methotrexate Alone |
Primary outcome
Change in Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months
Time frame: Baseline to 3 months
Change in disease activity assessed using the Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months. The DAS28-CRP score ranges from 0 to 9.4, with higher scores indicating greater rheumatoid arthritis disease activity (worse outcome).
3 secondary outcomes
Change in serum matrix metalloproteinase-3 (MMP-3) concentration from baseline to 3 months
Time frame: Baseline to 3 months
Number and percentage of participants experiencing at least one adverse drug reaction during the 3-month treatment period
Time frame: Baseline to 3 months
Number and percentage of participants with treatment discontinuation due to adverse drug reactions
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin, Empagliflozin and Methotrexate in people with Rheumatoid Arthritis (RA), run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enas A. El-Shorbagy, M.Sc. in Clinical Pharmacy (+201123339227, enas-elshorbagy@eru.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) from baseline to 3 months (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.